Before sending revised reports and, eventually, shutting its labs down, the embattled blood-testing firm Theranos provided some patients with dubious results that influenced their medical care, the Wall Street Journal reports.
For instance, it spoke with Steve Hammons, whose blood-clotting test results indicated that his blood took six times longer than normal to clot. As Hammons' test results from five visits within six weeks varied greatly, his doctor advised him to switch from warfarin to a less powerful medication. He later received a revised report for one test.
Additionally, the Journal recounts the story of Sheri Ackert whose testing indicated she had high estradiol levels. This led Ackert, who'd had a double mastectomy to treat breast cancer and who is past menopause, to worry that she might have an adrenal tumor. A repeat test by another firm, though, placed her estradiol level in the expected low range.
The Journal also reports that notes from the Centers for Medicare & Medicaid Services inspection of Theranos said that 29 percent of the quality-control checks that were conducted on the company's proprietary Edison instrument exceeded the company's threshold of two standard deviations from its average result. The company since voided Edison results from between 2014 and 2015 as well as the results of some tests run on other machines. Earlier this year, CMS sent the company a letter detailing deficiencies its inspection uncovered, and it later proposed banning company CEO Elizabeth Holmes from owning or operating a clinical lab for two years.
This month, the company announced it was closing its labs and shifting into platform and technology development.